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| ID | Type | Description | Link |
|---|---|---|---|
| K23DA041616 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Medical University of South Carolina | OTHER |
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A small-scale randomized controlled trial (RCT) will pilot test a personalized JITAI designed to guide delivery of fast acting nicotine replacement therapy (NRT; lozenge) in real-time, to prevent smoking relapse. Specifically, a smartphone application (app), will integrate pre-quit smoking data with objective location data captured via global positioning system (GPS) to establish relapse risk (hotspot) algorithms. During a quit attempt, the GPS-enabled app (QuitBuddy) will detect proximity to hotspots and deliver NRT prompts, all of which will occur automatically and prior to exposure. Thus, QuitBuddy will optimize NRT use to prevent cue-provoked cravings known to undermine sustained abstinence, thereby repurposing this evidence-based cessation medication to promote relapse prevention. QuitBuddy will be tested against standard care (NRT with brief instructions). Two versions of QuitBuddy will be tested, which will differ only in how hotspot algorithms are derived: retrospectively from locations recalled at the onset of a quit attempt (QuitBuddy-Recall) or based on real-time EMA completed pre-quit (QuitBuddy).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NRT + QuitBuddy | Experimental | This smartphone app will identify high-risk situations through real-time EMA data collected before and during a quit attempt. One week of pre-quit smoking behaviors will be integrated with passively sensed GPS data to create hotspot maps. Hotspot maps will provide interactive visualizations of relapse risk. GPS triggered NRT/behavioral prompts will occur when participants come within 50m from the centroid of a hotspot. |
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| NRT + QuitBuddy-Recall | Experimental | This smartphone app will identify high-risk situations through retrospective recall of locations where the patient typically smoked. Hotspot maps will provide interactive visualizations of relapse risk. GPS triggered NRT/behavioral prompts will occur when participants come within 50m from the centroid of a hotspot. |
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| NRT Control (treatment as usual) | Active Comparator | Standard Care Control is intended to approximate the real-world experience where smokers obtain over-the-counter NRT and, after brief instructions at the outset (~1 lozenge per hour, during cravings, and <20 per day), determine usage for themselves. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NRT + QuitBuddy | Other | QuitBuddy treatment app and 1 month supply of 4 mg nicotine lozenge |
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| Measure | Description | Time Frame |
|---|---|---|
| Abstinence from cigarettes | Biochemically-verified smoking status (CO<6) obtained at 3-month follow-up | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Abstinence from cigarettes | Biochemically-verified smoking status (CO<6) obtained at 1-month follow-up | 4 weeks |
| Abstinence from cigarettes | Biochemically-verified smoking status (CO<6) obtained at 1-week follow-up |
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Inclusion Criteria:
Exclusion Criteria:
FDA contraindications for use of NRT:
current use (past 30 days) of alternative tobacco products or smoking cessation medications
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| Name | Affiliation | Role |
|---|---|---|
| Bryan W Heckman, PhD | Meharry Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meharry Medical College | Nashville | Tennessee | 37208 | United States |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000095488 | Nicotine Replacement Therapy |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
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| NRT + QuitBuddy-Recall | Other | QuitBuddy-Recall treatment app and 1 month supply of 4 mg nicotine lozenge |
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| Treatment as Usual | Other | 1 month supply of 4 mg nicotine lozenge |
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| 1 week |